|By PR Newswire||
|February 10, 2014 09:03 AM EST||
MARIETTA, Ga., Feb. 10, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that Medicare contractor, Noridian Healthcare Solutions, LLC, has confirmed that the Company's wound care allograft, EpiFix®, has been approved to receive reimbursement coverage.
The coverage from Noridian becomes effective March 1, 2014, and brings the total Medicare Administrative Contractors (MACs) covering EpiFix to seven of the eight. The Noridian jurisdictions include Washington, Oregon, Idaho, Alaska, North Dakota, South Dakota, Montana, Wyoming, Utah, Arizona, California, Nevada and Hawaii. The only remaining MAC needed to approve EpiFix coverage is First Coast Service Options (FCSO), whose jurisdiction is the State of Florida. Thus, EpiFix, now has coverage in 49 of the 50 states.
"Noridian has approved EpiFix for both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) that fail to respond to standard of care treatments. Two of the largest categories of chronic wounds are DFUs and VLUs", commented Parker H "Pete" Petit, Chairman & CEO. In the U.S., approximately 1 million patients per year are reported to be suffering from DFUs and nearly 900,000 patients each year are reported to suffer from VLUs.
"The success of EpiFix in attaining coverage from the MACs and many of the commercial health plans and state Medicaid programs is based on our clinical study data presented to those health plans. Also included in this clinical data are the results from another recently completed Randomized Control Trial (RCT) that is expected to be published shortly," commented Bill Taylor, President & COO. "In this study, patients were enrolled following a 2-week run-in period, after having been treated with 4 weeks of conventional therapy. Those patients exhibiting rapid healing (wound reduction of more than 50%) at the conclusion of 'run-in period' were excluded. EpiFix was either utilized weekly or bi-weekly on 40 patients. In both groups, EpiFix achieved wound closure in 70% of patients in 4 weeks. Furthermore, 92.5% of the overall population exhibited healing at 12 weeks with EpiFix. The mean time to closure for the weekly applications was 17 days, and 25 days for bi-weekly applications. Pooling this data with the previously published EpiFix data, on patients who did not heal with conventional therapy after four weeks of conventional therapy and a subsequent two week 'run-in period', EpiFix healed 52 of 64 (81%) of patients in 6 weeks, 58 of 64 (91%) of patients in 9 weeks, and 59 of 64 (92%) of patients in 12 weeks. The median time to closure of the 58 healed patients was 14 days," added Taylor.
A clinical study published July 24, 2013 in JAMA Dermatology, a peer reviewed journal published by the American Medical Association, reports that the median size of a DFU is 1.35 square centimeters and the median size of a VLU is 2.32 square centimeters. Taylor stated, "The legacy skin substitute products most widely approved by commercial health plans are only offered in fixed sheet sizes of approximately 40 square centimeters. This leads to a tremendous amount of wastage in treating both DFUs and VLUs. The MiMedx EpiFix allograft comes in sizes ranging from 1.5 square centimeters on up, allowing for size-appropriate grafts, particularly for these wound types."
"Coupling the robust clinical results with the cost effectiveness of EpiFix, we expect a continuing rapid rate of health plan and state Medicaid reimbursement coverage in the months ahead," concluded Petit.
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 200,000 allografts to date for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the clinical and cost effectiveness of EpiFix®, the prospect of additional reimbursement approvals from the remaining Medicare Administrative Contractor and other commercial health care plans and state Medicaid programs, and the opportunities presented by the Noridian coverage determination. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the remaining Medicare Administrative Contractor will not approve EpiFix® for reimbursement, that other commercial plans and state Medicaid programs will not approve EpiFix for reimbursement coverage, that we will be unable to capitalize on the opportunity for expanded sales of our EpiFix® allografts, that EpiFix® will not perform as expected or will not gain acceptance in the medical community, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2012, and the Company's Forms 10-Q filed in 2013. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.